# K031424: Ebi Spinelink Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Jul 22, 2003 after 77 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Spinal Concepts BacFix Spinal Fixation System: named in the summary without a submission number
- (no number) Sofamor Danek CD Spinal System: named in the summary without a submission number
- (no number) Sofamor Danek Townley Pedicle Screw Plating System: named in the summary without a submission number

## Indications for use
The EBI® SpineLink® Spinal Fixation System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and or lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion. The transverse connector is not intended for anterior/anterolateral fixation.

Source page: https://510kreport.com/device/K031424
Methodology: https://510kreport.com/methodology